The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex, Inc.) with the FDA for Cg+ Arrow Jacc Powered By Arrow Vps Stylet, Cg+ Arrow Jacc.
| Device ID | K153423 |
| 510k Number | K153423 |
| Device Name: | CG+ Arrow JACC Powered By Arrow VPS Stylet, CG+ Arrow JACC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Julie Lawson |
| Correspondent | Julie Lawson ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) 2400 BERNVILLE ROAD Reading, PA 19605 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-11-25 |
| Decision Date | 2016-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902191131 | K153423 | 000 |
| 20801902188599 | K153423 | 000 |
| 20801902188582 | K153423 | 000 |
| 20801902188421 | K153423 | 000 |
| 20801902188575 | K153423 | 000 |
| 20801902188568 | K153423 | 000 |
| 20801902188339 | K153423 | 000 |
| 20801902188322 | K153423 | 000 |
| 20801902188315 | K153423 | 000 |